Metabolic Effects of Endogenous Bile Acids After Gastric Bypass Surgery
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHvidovre University Hospital
About this trial
Non-randomized, open-label, parallel-group clinical study evaluating the effects of endogenous bile acids on changes in plasma fibroblast growth factor-19 (FGF-19) and glucose metabolism by extended depletion of circulating bile acids using colesevelam as an experimental tool in subjects operated with gastric by-pass (RYGB).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
RYGB-operated ≥ 18 months prior to inclusion
History of diabetes prior to RYGB (HbA1c ≥48 mmol/mol or use of antidiabetic medication)
HbA1c <58 mmol/mol on no antidiabetic medication or metformin alone
Weight change < ±3 kg for >3 months at time of inclusion
Disqualifiers
Pregnancy or breastfeeding
Haemoglobin < 6.5 mmol/L at time of inclusion
Fasting plasma glucose > 10.0 mmol/L at time of inclusion
Prior cholecystectomy
Trial design
Design model
Single group
Treatments tested in this trial
Colesevelam
DrugColesevelam is an approved drug with well known adverse events. Gastrointestinal side effects (Obstipation, flatulence, abdominal pain, diarrhea, nausea, meteorism, vomiting, chanced faeces) are very common (\>10%) or common (1-10%), but are mild and tolerable in most cases. All participants will be monitored closely, and colesevelam will be discontinued if the subject experience unreserved adverse events. All effects of colesevelam are transient (17-19) as the compound is not absorbed to the systemic circulation, i.e. treatment effects cease when the drug is excreted from the intestine. Specifically, no permanent metabolic effects of colesevelam has been observed in crossover experiments (27). Therefore, 8 weeks of colesevelam treatment as planned in the current study will have no long lasting positive or negative effects on the participants.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: 3.75 mg Colesevelam in 8 weeksExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Glucose
Changes in total areal under the curve (AUC) of plasma glucose concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Time frame
8 weeks2
FGF-19
Changes in total AUC of plasma FGF-19 concentrations during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Time frame
8 weeksOther outcomes
1
Explorative outcomes, glucose
Plasma glucose concentration during the mixed meal test after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Time frame
8 weeks2
Explorative outcomes, Bile acids
after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Time frame
8 weeks3
Explorative outcomes, FGF-19
after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Time frame
8 weeks4
Explorative outcomes, cholecystokinin (CCK)
after 8 weeks of colesevelam-induced depletion of endogenous bile acids (V4) compared with baseline in the intervention group (V2).
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov